Z-1897-2017Class II

BD FlowSmart Set MiniMed Pro-set Rx Only Distributed by Medtronic MiniMed Inc. 8006464633 8185765555 Legal...

Name: Z-1897-2017 BD FlowSmart Set MiniMed Pro-set Rx Only Distributed by Medtronic MiniMed Inc. 8006464633 8185765555 Legal...
Creator: Becton Dickinson & Company
Published: 2016-12-23
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2016-12-23 / Terminated / root cause: design

FDA source

Becton Dickinson & Company began a recall of BD FlowSmart Set MiniMed Pro-set Rx Only Distributed by Medtronic MiniMed Inc. 8006464633 8185765555 Legal Manufacturer Becton, Dickinson and Company USA BD... on 2016-12-23. FDA classified it as Class II and gives the reason as "Patients are reporting high blood glucose (HBG) levels while using the MiniMed Pro-set and also noticed the catheter of the infusion set was bent/kinked". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1897-2017
Classification: Class II
Status: Terminated
Initiated: 2016-12-23
Posted: 2017-05-01
Terminated: 2017-11-09
Recalling firm: Becton Dickinson & Co
Product: BD FlowSmart Set MiniMed Pro-set Rx Only Distributed by Medtronic MiniMed Inc. 8006464633 8185765555 Legal Manufacturer Becton, Dickinson and Company USA BD Medical-Diabetes Care Becton Dickinson France SAS
Product code: FPA Set, Administration, Intravascular
Reason for recall: Patients are reporting high blood glucose (HBG) levels while using the MiniMed Pro-set and also noticed the catheter of the infusion set was bent/kinked.
Root cause tag: design
FDA root cause: Device Design
Action: Becton Dickinson (BD) notified their sole customer Medtronic via e-mail on December 26, 2016. BD recommends that Medtronic notify their customers of the situation. For further questions, please call (201) 847-6800.
Quantity in commerce: 57,750 units
Distribution: US Distribution to the state of : CA
Product codes and lots: 6203871 30-Jun-19 6203860 30-Jun-19 6207535 30-Jun-19 6211649 31-Jul-19 6207537 30-Jun-19 6211650 31-Jul-19

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1897-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1897-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-10	2017-05-01

Product code FPA

K160651Class IIBD FlowSmart Set, MiniMed Pro-SetBecton, Dickinson and Company / cleared 2016-04-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)